Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, Santiago de Compostela, Spain.
Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, UK.
Expert Opin Drug Deliv. 2024 Nov;21(11):1665-1681. doi: 10.1080/17425247.2024.2399706. Epub 2024 Sep 18.
Adrenal insufficiency is usually diagnosed in children who will need lifelong hydrocortisone therapy. However, medicines for pediatrics, in terms of dosage and acceptability, are currently unavailable.
Semi-solid extrusion (SSE) 3D printing (3DP) was utilized for manufacturing of personalized and chewable hydrocortisone formulations (printlets) for an upcoming clinical study in children at Vall d'Hebron University Hospital in Barcelona, Spain. The 3DP process was validated using a specific software for dynamic dose modulation.
The printlets contained doses ranging from 1 to 6 mg hydrocortisone in three different flavor and color combinations to aid adherence among the pediatric patients. The pharma-ink (mixture of drugs and excipients) was assessed for its rheological behavior to ensure reproducibility of printlets through repeated printing cycles. The printlets showed immediate hydrocortisone release and were stable for 1 month of storage, adequate for prescribing instructions during the clinical trial.
The results confirm the suitability and safety of the developed printlets for use in the clinical trial. The required technical information from The Spanish Medicines Agency for this clinical trial application was compiled to serve as guidelines for healthcare professionals seeking to apply for and conduct clinical trials on 3DP oral dosage forms.
肾上腺功能不全通常在需要终身接受氢化可的松治疗的儿童中诊断。然而，儿科用药在剂量和可接受性方面目前尚无法获得。
半固态挤出（SSE）3D 打印（3DP）用于制造个性化和可咀嚼的氢化可的松制剂（打印片），以供即将在西班牙巴塞罗那 Vall d'Hebron 大学医院的儿童进行临床研究。该 3DP 工艺使用特定的软件进行动态剂量调制进行了验证。
打印片中含有 1 至 6 毫克的氢化可的松剂量，有三种不同的口味和颜色组合，以帮助儿科患者坚持用药。药物墨水（药物和赋形剂的混合物）的流变性进行了评估，以确保通过重复打印循环实现打印片的重现性。打印片表现出即刻释放的氢化可的松，并在储存 1 个月内稳定，足以满足临床试验期间的处方说明。
结果证实了所开发的打印片在临床试验中的适用性和安全性。为了满足该临床试验申请，编译了西班牙药品管理局的所需技术信息，为寻求申请和进行 3DP 口服剂型临床试验的医疗保健专业人员提供了指导。
